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Treatment of Breast Pain Using A Medication (Diclofenac) Applied to the Skin

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ClinicalTrials.gov Identifier: NCT00276419
Recruitment Status : Terminated (Lack of funds; FDA approved a topical form of diclofenac during study, no need to continue study of pharmacy-compounded drug.)
First Posted : January 13, 2006
Results First Posted : December 13, 2012
Last Update Posted : December 20, 2012
Sponsor:
Information provided by:
Mayo Clinic

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Breast Pain
Non-cyclical Mastalgia
Surgical Scar-Related Breast Pain
Interventions Drug: Diclofenac
Drug: Placebo
Enrollment 25
Recruitment Details 25 Participants were recruited at the Mayo Clinic in Rochester Minnesota from June 2005 to May 2009. Seven subjects withdrew after randomization, prior to treatment, 6 in arm A, and 1 in arm B.
Pre-assignment Details  
Arm/Group Title Placebo First, Then Diclofenac (Arm A) Diclofenac First, Then Placebo (Arm B)
Hide Arm/Group Description Placebo for Diclofenac in topical cream applied to the skin three times daily for 10 weeks, then compounded topical Diclofenac cream applied to the skin three times daily for 10 weeks. Compounded topical Diclofenac cream applied to the skin three times daily for 10 weeks, then placebo for Diclofenac in topical cream applied to the skin three times daily for 10 weeks.
Period Title: First Intervention
Started 8 10
Completed 7 8
Not Completed 1 2
Reason Not Completed
Adverse Event             1             0
Withdrawal by Subject             0             2
Period Title: Wash-out Phase
Started 7 8
Completed 7 8
Not Completed 0 0
Period Title: Second Intervention
Started 7 8
Completed 7 8
Not Completed 0 0
Arm/Group Title Placebo First, Then Diclofenac (Arm A) Diclofenac First, Then Placebo (Arm B) Total
Hide Arm/Group Description Placebo for Diclofenac in topical cream applied to the skin three times daily for 10 weeks, then compounded topical Diclofenac cream applied to the skin three times daily for 10 weeks. Compounded topical Diclofenac cream applied to the skin three times daily for 10 weeks, then placebo for Diclofenac in topical cream applied to the skin three times daily for 10 weeks. Total of all reporting groups
Overall Number of Baseline Participants 8 10 18
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 10 participants 18 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
8
 100.0%
10
 100.0%
18
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 10 participants 18 participants
Female
8
 100.0%
10
 100.0%
18
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 8 participants 10 participants 18 participants
8 10 18
1.Primary Outcome
Title Frequency of Breast Pain
Hide Description Participants will complete a breast pain diary indicating the sensation of pain on a daily basis. The frequency of breast pain will be determined by the number of days per week that the subject recorded experiencing pain at 4 weeks and 10 weeks of each treatment.
Time Frame 4 weeks, 10 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo First, Then Diclofenac (Arm A) Diclofenac First, Then Placebo (Arm B)
Hide Arm/Group Description:
Placebo for Diclofenac in topical cream applied to the skin three times daily for 10 weeks, then compounded topical Diclofenac cream applied to the skin three times daily for 10 weeks.
Compounded topical Diclofenac cream applied to the skin three times daily for 10 weeks, then placebo for Diclofenac in topical cream applied to the skin three times daily for 10 weeks.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Primary Outcome
Title Severity of Breast Pain
Hide Description Severity will measured using a 100 mm visual analog scale (VAS). The VAS does not have any pre-set marks between the extremes. For the pain severity VAS, 0 means no pain and 100 means extreme pain. The investigator measures the written mark of the participant in mm, and records this for the value of pain severity. The severity of breast pain will be determined by the mean of breast pain scores (determined for all days and for days for which pain is greater than 0) at 4 weeks and 10 weeks of each treatment.
Time Frame 4 weeks, 10 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo First, Then Diclofenac (Arm A) Diclofenac First, Then Placebo (Arm B)
Hide Arm/Group Description:
Placebo for Diclofenac in topical cream applied to the skin three times daily for 10 weeks, then compounded topical Diclofenac cream applied to the skin three times daily for 10 weeks.
Compounded topical Diclofenac cream applied to the skin three times daily for 10 weeks, then placebo for Diclofenac in topical cream applied to the skin three times daily for 10 weeks.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Mean Days of Pain During the 10 Week Treatment Periods
Hide Description Participants will complete a breast pain diary indicating the sensation of pain on a daily basis. Mean number of days with pain during each 10 week treatment period will be calculated.
Time Frame Approximately 12 weeks and at 24 weeks after randomization
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo First, Then Diclofenac (Arm A) Diclofenac First, Then Placebo (Arm B)
Hide Arm/Group Description:
Placebo for Diclofenac in topical cream applied to the skin three times daily for 10 weeks, then compounded topical Diclofenac cream applied to the skin three times daily for 10 weeks.
Compounded topical Diclofenac cream applied to the skin three times daily for 10 weeks, then placebo for Diclofenac in topical cream applied to the skin three times daily for 10 weeks.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Adverse events were collected over the 22 weeks of the study.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Diclofenac
Hide Arm/Group Description Placebo for Diclofenac in topical cream applied to the skin three times daily for 10 weeks Compounded topical Diclofenac cream applied to the skin three times daily for 10 weeks.
All-Cause Mortality
Placebo Diclofenac
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Diclofenac
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/18 (0.00%)      0/18 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Diclofenac
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/18 (5.56%)      1/18 (5.56%)    
General disorders     
Infection grade 2   1/18 (5.56%)  1 0/18 (0.00%)  0
Skin and subcutaneous tissue disorders     
Dry skin of hand and scalp   0/18 (0.00%)  0 1/18 (5.56%)  1
Indicates events were collected by systematic assessment
This study was terminated early due to lack of funds; the FDA approved a topical form of diclofenac during study, therefore there was no need to continue study of pharmacy-compounded drug.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Robin L. Smith
Organization: Mayo Clinic
Phone: 507-284-1210
EMail: smith.robin@mayo.edu
Layout table for additonal information
Responsible Party: Robin L. Smith, MD; principal investigator, Division of General Internal Medicine, Mayo Clinic, Rochester Minnesota
ClinicalTrials.gov Identifier: NCT00276419     History of Changes
Other Study ID Numbers: 92-05
First Submitted: January 11, 2006
First Posted: January 13, 2006
Results First Submitted: November 16, 2012
Results First Posted: December 13, 2012
Last Update Posted: December 20, 2012